Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

KNW 2017-06-19

Möller Medical Biopsy Needles and Systems

Applicant Moller Medical GmbH

K-Number K162588

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NDC 2017-06-19

Insulia Diabetes Management Companion

Applicant Voluntis Sa.

K-Number K170669

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MCW 2017-06-16

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System

Applicant Medtronic Vascular, Inc.

K-Number K170191

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OAS 2017-06-16

Green16/Green18 (Model: PHT-65LHS)

Applicant VATECH Co., Ltd.

K-Number K170066

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OWB 2017-06-16

Infinix INFX-8000V, V6.40

Applicant Toshiba Medical Systems Coroporation

K-Number K170909

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GEX 2017-06-16

Diode Laser Hair Removal System

Applicant Shandong Huamei Technology Co., Ltd.

K-Number K162659

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HRS 2017-06-16

Alians Fragment Specific

Applicant Newclip Technics

K-Number K170843

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FGE 2017-06-16

Quantum TTC Biliary Balloon Dilator

Applicant Wilson-Cook Medical, Inc.

K-Number K171223

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OWQ 2017-06-16

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

Applicant Innovative Health, LLC

K-Number K170474

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LCP 2017-06-16

A1C EZ Glycohemoglobin Analysis System

Applicant Biohermes Co., Ltd.

K-Number K161533

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OBP 2017-06-16

MagVita TMS Therapy System

Applicant Tonica Elektronik A/S

K-Number K171481

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DWF 2017-06-16

Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae

Applicant Sorin Group Italia S.R.L.

K-Number K162215

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